Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin and Degarelix.

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms.

Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 42 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patient has given written informed consent before any trial-related activity is performed. Has a confirmed prostate cancer in which this type of treatment is needed.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: previous treatment for prostate cancer; previous trans-urethral resection of the prostate; patients in need of external beam radiotherapy to be started at the same time as hormone therapy.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-04 with completion listed for 2010-06.

It ran at 33 sites in Spain (13), Germany (10) and United Kingdom (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 (time frame: After treatment of 12 weeks compared to Baseline).

It also tracked 9 secondary outcomes, for example Change From Baseline in Total IPSS at Weeks 4 and 8, Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit, Change From Baseline in Residual Volume (Vresidual) at Each Visit, Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12, Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit and Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin and Degarelix in 42 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Goserelin compound page and the Degarelix compound page, all human trials.